Clinical Research Project Manager

Biotrial; Newark (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Biotrial in Newark, NJ seeks a Clinical Research Project Manager to provide customer-focused leadership and oversee clinical trial projects, ensuring alignment with ICH/GCP and regulatory requirements.

Reporting to the Associate Director, Clinical Operations, you will coordinate sponsor communications, develop study timelines, manage budgets and vendor contracts, and drive on-time enrollment and study delivery across sites.

Qualifications

• Requires a B.S. degree in life sciences or related field.
• Minimum 2 years in managing projects in a CRO or industry. Experience in monitoring clinical studies is a plus.
• Excellent written and verbal communication skills, as well as interpersonal skills.
• Ability to interact with all levels of management, sponsor and study site personnel.
• Detail-oriented and possess good troubleshooting skills with the ability to prioritize and execute tasks in a high-pressure environment.

Responsibilities

• Manage and coordinate the activities of clinical trials with the Biotrial Project Team (CRA, clinical team, Data Managers, Statisticians, Medical Writers, etc.).
• Serve as the main point of contact and communicate with sponsors regarding project timelines, updates, needs and emerging issues.
• Develop study timelines based on protocols.
• Ensure project start-up activities by facilitating processes for preparation of regulatory documents, ensuring timely IRB/IEC approvals for clinical trials.
• Lead internal project meetings including Kick-off meetings and Study Initiation meetings with sponsors/internal teams.
• Follow screening and recruitment activities to ensure timely enrollment in the trials.
• Organize and coordinate Safety Review Meetings with Investigator / sub-investigator / Medical and scientific affair members.
• Monitor and ensure that project scope and deliverables are fulfilled within timelines and budget.
• Support and coordinate with the Medical Writing team to ensure completion of the Clinical Study Report, as applicable.
• Review and manage study contracts/budgets. Collaborate with Billing and Accounts Department to ensure billing agrees with pre-established milestones.
• Review and approve Vendor/Site contracts, budgets and invoices.
• Regularly and in a timely fashion, interact with management, sponsors, and/or functional team members on matters concerning resource allocation, project milestones, regulatory issues, and other relevant issues.
• Organize sponsors' visit of the Clinical Pharmacology Unit (Site qualification visits, Initiation Meetings, Monitoring visits and Close-out visits).
• Occasional travel may be required for bid defense, initiation or kick-off meetings, or other study-related activities.

Skills

Project management

Communication skills

Interpersonal skills

Microsoft Office Suite

Education

B.S. degree in life sciences or related field

Tools

Microsoft Office Suite

Job description

Biotrial, a leading provider of high-quality pharmacology services, is currently recruiting a Clinical Research Project Manager for Newark, NJ, US. With over 35 years of experience in providing scientific and medical services in Clinical Development, Biotrial possesses one of the largest clinical capacities in Europe and the U.S.

The Clinical Research Project Manager is responsible for providing customer-focused leadership and project oversight. This position facilitates communication among team members, including sponsor personnel and the Biotrial Project Team. The Clinical Research Project Manager proactively solves issues and oversees the successful implementation and monitoring of clinical trials to ensure that those are conducted in accordance with ICH/GCP and applicable regulations.

This position is based and will work in the Newark, New Jersey Clinical Pharmacology facility.

Responsibilities

Under the supervision of the Associate Director, Clinical Operations, duties and responsibilities relative to the management of Clinical trials will include, but will not be limited to:

• Manage and coordinate the activities of clinical trials with the Biotrial Project Team (CRA, clinical team, Data Managers, Statisticians, Medical Writers, etc.).
• Serve as the main point of contact and communicate with sponsors regarding project timelines, updates, needs and emerging issues.
• Develop study timelines based on protocols.
• Ensure project start-up activities by facilitating processes for preparation of regulatory documents, ensuring timely IRB/IEC approvals for clinical trials.
• Lead the internal project meetings including Kick-off meetings and Study Initiation meetings, etc. with sponsors/internal teams.
• Follow screening and recruitment activities to ensure timely enrollment in the trials.
• Organize and coordinate Safety Review Meetings with Investigator / sub-investigator / Medical and scientific affair members.
• Monitor and ensure that project scope and deliverables are fulfilled within timelines and budget.
• Support and coordinate with the Medical Writing team to ensure completion of the Clinical Study Report, as applicable.
• Review and manage study contracts/budgets. Collaborate with Billing and Accounts Department to ensure billing agrees with pre-established milestones.
• Review and approve Vendor/Site contracts, budgets and invoices.
• Regularly and in a timely fashion, interact with management, sponsors, and/or functional team members on matters concerning resource allocation, project milestones, regulatory issues, and other relevant issues.
• Organize sponsors' visit of the Clinical Pharmacology Unit (Site qualification visits, Initiation Meetings, Monitoring visits and Close-out visits).
• Occasional travel may be required for bid defense, initiation or kick-off meetings, or other study-related activities.

Requirements

• Requires a B.S. degree in life sciences or related field.
• Minimum 2 years in managing projects in a Contract Research Organization (CRO) or industry. Experience in monitoring clinical studies is a plus.
• Good understanding of the drug development process.
• Excellent written and verbal communication skills, as well as interpersonal skills.
• Ability to interact with all levels of management, sponsor and study site personnel.
• Detail-oriented and possess good troubleshooting skills with the ability to prioritize and execute tasks in a high-pressure environment.
• Possess good trouble-shooting skills with the ability to prioritize and execute tasks in a high-pressure environment.
• Proficient computer skills in Microsoft Office Suite.

By joining our Company, you become part of a high-performing organization. Teamwork and cooperation allow us to offer state-of-the-art services. The successful candidate will enjoy working in a multicultural environment and interacting in a supportive manner with different functional areas and locations.

Equal Opportunity Employer

Biotrial is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, genetics, disability, age, veteran status, or any other characteristic protected by law.